Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00404703
Recruitment Status : Terminated (Primary (safety) endpoint reached)
First Posted : November 29, 2006
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE November 28, 2006
First Posted Date  ICMJE November 29, 2006
Last Update Posted Date August 24, 2016
Study Start Date  ICMJE August 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2008)
Rate of grade >=3 Avastin-related pulmonary hemorrhage [ Time Frame: After a maximum of 12 months treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2006)
Rate of grade >= 3 Avastin-related pulmonary hemorrhage
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2008)
  • Overall response, duration of response, progression-free survival. [ Time Frame: Event driven ]
  • AEs, laboratory parameters, coagulation parameters. [ Time Frame: Throughout study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2006)
Efficacy: Overall response, duration of response, progression-free survival. Safety:AEs, laboratory parameters, coagulation parameters.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Avastin (Bevacizumab) in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer
Official Title  ICMJE An Open Label Study of the Safety of First-line Treatment With Avastin in Combination With Cisplatin-gemcitabine or Carboplatin-paclitaxel in Patients With Advanced or Recurrent Squamous Non-small Cell Lung Cancer, Who Are Considered to be at High Risk of Pulmonary Haemorrhage
Brief Summary This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: bevacizumab [Avastin]
    15mg iv on day 1 of each 3 week cycle
  • Drug: Platinum-based chemotherapy
    As prescribed
Study Arms  ICMJE Experimental: 1
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: Platinum-based chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 23, 2016)
37
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • documented squamous non-small cell lung cancer;
  • stage IIIb with pleural or pericardial effusion, stage IV, or recurrent disease;
  • suitable for platinum-based treatment as first line chemotherapy.

Exclusion Criteria:

  • prior systemic anti-tumor therapy;
  • prior radiotherapy for treatment of patient's current stage of disease;
  • other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;
  • major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Czech Republic,   France,   Hungary,   Israel,   Poland,   Russian Federation,   Spain,   Taiwan
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT00404703
Other Study ID Numbers  ICMJE BO19734
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP